A Study to Evaluate the Efficacy of Seattle-PAP for the Respiratory Support of Premature Infants
Primary Purpose
Premature Birth
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Seattle-PAP
Conventional bubble nasal CPAP
Sponsored by

About this trial
This is an interventional treatment trial for Premature Birth focused on measuring bubble nasal continuous positive airway pressure, respiratory support
Eligibility Criteria
Inclusion Criteria:
- Informed consent from parents, less than 30 weeks postmenstrual age at birth, within 72 h of postnatal age spontaneously breathing and able to sustain SaO2 of greater than 90% on less than or equal to FiO2 of 0.40 and 6 cm H2O pressure
Exclusion Criteria:
- Cardiopulmonary malformations (cardiac valve atresia, lung atresia)
- Congenital malformations (examples: anencephaly, omphalocele, Tetralogy of Fallot) Genetic anomalies (examples: Trisomy 21, Trisomy 18).
Sites / Locations
- Nationwide Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Seattle-PAP
Conventional bubble nasal CPAP
Arm Description
bubble nasal cpap respiratory support with Seattle-PAP bubbler device, with all other aspects of care per usual care noninvasive respiratory support
qualified and enrolled infants randomized to this arm will receive noninvasive respiratory support by bubble nasal CPAP, using the Fisher & Paykel bubbler, which is the standard of care at Nationwide Children's.
Outcomes
Primary Outcome Measures
Failure of noninvasive respiratory support
The primary endpoint of this study is the cumulative incidence of respiratory failure requiring intubation. The principal criteria for failure of support are the requirement of an FiO2 greater than 0.40 and CPAP of greater than 6 cm H2O to maintain SaO2 of at least 90%. Support failure also can be declared by the responsible clinician based on best clinical judgment, but any declarations not based on the stated criteria will require written explanations.
Secondary Outcome Measures
pneumothorax
by diagnosis of clinical care team
nasal trauma
by diagnosis of clinical care team
supplemental oxygen requirement
if an infant fails for one hour or more fails to sustain an oxygen saturation (SaO2) of at least 90 percent, with FiO2 of 0.40 or less and 6 cm of water pressure (cmH2O) or less CPAP pressure.
ventilation-associated sepsis
by diagnosis of clinical care team
death of infant
infant declared dead by responsible clinical care personnel
Central nervous system (CNS) injury
intraventricular hemorrhage and/or periventricular leukomalacia
gastrointestinal complications
necrotizing enterocolitis and/or spontaneous intestinal perforation
retinopathy of prematurity
by diagnosis of clinical care team
Full Information
NCT ID
NCT03085329
First Posted
March 6, 2017
Last Updated
March 20, 2017
Sponsor
Seattle Children's Hospital
Collaborators
Nationwide Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03085329
Brief Title
A Study to Evaluate the Efficacy of Seattle-PAP for the Respiratory Support of Premature Infants
Official Title
A Study to Evaluate the Efficacy of Seattle-PAP for the Respiratory Support of Premature Infants
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 10, 2017 (Actual)
Primary Completion Date
October 31, 2018 (Anticipated)
Study Completion Date
February 9, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital
Collaborators
Nationwide Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is designed to test the hypothesis that among infants born at less than 30 weeks, weighing less than 1500 g at delivery, and receiving initial respiratory support non-invasively or on invasive respiratory support and meeting extubation criteria in the first 72 h of life, fewer neonates managed on Seattle--PAP will require endotracheal intubation and conventional mechanical ventilation (CMV) than will neonates managed from birth on bubble nasal continuous positive airway pressure (Bn-CPAP) using the Fischer- & Paykel (FP) device. Neonates on nasal continuous positive airway pressure (CPAP) in the delivery room or who are stabilized on mechanical ventilation as their initial form of respiratory support and meet our criteria for extubation within 72 h of birth will be eligible for randomization and study.
The primary endpoint of this study is the cumulative incidence of respiratory failure requiring intubation that occurs in patients after randomization and before 36 weeks post menstrual age (PMA) or discharge, whichever comes first. Presently, the literature supports that this age group typically exhibits intubation rates of 50% or more, which is consistent with the data from the Nationwide Children's Hospital/Ohio State University (NCH/OSU) Neonatal Intensive Care Unit (NICU).
Detailed Description
Parents / Mothers with impending pre-term delivery at <30 weeks of gestation will be approached for informed consent to participate. If consent is given prior to delivery, upon delivery the neonate may be randomly assigned to either Fisher & Paykel CPAP (conventional approach) or Seattle--PAP (experimental approach).
First 72 hours of life: 1) Neonates able to breathe spontaneously on less than 40% oxygen after initial resuscitative efforts and would normally be placed on CPAP will be randomly assigned to one of the two treatment groups using sealed cards generated by a variable block randomization scheme. 2) Neonates requiring increased support after initial resuscitation (intubation, >40% oxygen by CPAP) will not initially be randomized. However, if within the first 72 hours of life, the infant meets NCH criteria for extubation, randomization to CPAP delivery method will be performed. 3) Neonates born at <30 weeks gestation who were intubated at birth and are unable to be weaned from ventilator support will be removed from the study.
72 Hours - 32 Weeks of Life: 1) Neonates from the first period (First 72 Hours of Life, above) who remain on CPAP will continue on randomly assigned CPAP methodology. 2) Neonates from the first period, who failed stabilization on CPAP and required intubation, but are able to be extubated to CPAP will be placed back on their assigned CPAP method. 3) Attempts will be made to wean back to assigned CPAP method any neonates who are >72 hours old and require intubation beyond this period for any reason. 4) If unable to wean back to CPAP prior to 32 weeks of age, these patients will be removed from the study.
CPAP Failure (Sub-Group 1): For the neonates initially assigned to CPAP in the delivery room (sub-group 1), respiratory failure secondary to hyaline membrane disease is recognized as a common occurrence. If a patient assigned to this group, regardless of CPAP methodology, requires a fraction of inspired oxygen (FiO2) greater than 0.40 on CPAP of 6 cm of water (H2O), or is deemed to require intubation for adequate oxygenation, this will be considered a failure of CPAP stabilization. These patients, however, may remain in the study if it becomes clinically feasible to return them back to their assigned CPAP method prior to 72 hours of life. If this is unable to be done, they will be removed from the study.
CPAP Failure (Sub-Group 2): Any neonate that requires FiO2 greater than 0.40 on CPAP of 6 cm H2O or intubation beyond the first 72 hours of life will also be considered CPAP failures. Like those assigned to sub-group 1, these patients may remain in the study if it becomes clinically feasible to return them back to their assigned CPAP method prior to 32 weeks of life. If this is unable to be done, they will be removed from the study.
All patients who are not removed from the study as outlined above or due to other unforeseen circumstances will be monitored to discharge for any change in ventilation and ventilation requirement status. Routine care, including clinical exams and procedures (echocardiography, ultrasound, eye exams, x--rays) that would be considered standard of care for these patients will be performed at the medical discretion of the assigned care providers. No changes other than the type of CPAP device used (if applicable) will be necessary to routine practice.
Transfers to NCH: [From Outside Hospital] - Neonates born at an outside institution who meet the inclusion criteria (<30 weeks GA, able to spontaneously breathe by 72 hours of life or were initially placed on CPAP and failed, <32 weeks of age) and whose parents can be reached to obtain consent will be considered for inclusion in this research study. [Transfers from Ohio State University (OSU) Hospital] - It is recognized that many neonates born at OSU will require transport to NCH for further medical care. Having fulfilled inclusion criteria at OSU, transport to NCH will not result in removal from the study.
Cardiopulmonary Monitoring: All neonates are monitored in the NICU using pulse oximetry as part of normal practice. Many potential subjects in this study are also monitored through blood tests and arterial catheters, the latter of which are normally not intended for long term use.
Pressure Monitoring: A stand-alone Data Acquisition and Recording Instrument (DARCI) that measures pressure (i.e., positive airway pressure [PAW]) will be attached to the ventilation circuit. The DARCI unit is equipped with a standard International Organization for Standardization (ISO)19054 pole mount fitting attached on the back. A medical grade plug-in transformer provides electrical power (120 volts alternating current (AC) to 5 volts direct current (DC)). An internal battery and on-board non-volatile memory provide continuous data processing and storage in the event of power interruption or loss. A start button with a green light emitting diode (LED) and a stop button with a red LED provide the operational interface to the user during setup and changes in ventilation circuits. Initial programming and downloading of recorded pressure data will be accomplished using a laptop personal computer (PC) with interface application software installed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
bubble nasal continuous positive airway pressure, respiratory support
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
With written informed consent from the mother or parents, infants born at less than 30 weeks gestation and who are capable of breathing spontaneously within the first 72 hours postnatal, will be supported by bubble nasal continuous positive airway pressure (Bn-CPAP), randomized to the standard device from Fisher & Paykel or to Seattle-PAP.
Masking
None (Open Label)
Masking Description
The nature of this comparative study makes masking device assignment impractical. The objectivity of the outcome assessment will rely upon adherence to formally defined criteria for device support failure.
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Seattle-PAP
Arm Type
Experimental
Arm Description
bubble nasal cpap respiratory support with Seattle-PAP bubbler device, with all other aspects of care per usual care noninvasive respiratory support
Arm Title
Conventional bubble nasal CPAP
Arm Type
Experimental
Arm Description
qualified and enrolled infants randomized to this arm will receive noninvasive respiratory support by bubble nasal CPAP, using the Fisher & Paykel bubbler, which is the standard of care at Nationwide Children's.
Intervention Type
Device
Intervention Name(s)
Seattle-PAP
Intervention Description
Seattle-PAP is a modified bubble CPAP device that has been given 510(k) clearance by the US FDA (K131502, October 11, 2013) and is thus recognized as substantially equivalent to other approved devices on the market. Results of a recently completed study in infants indicate that Bn-CPAP is associated with lower effort to breathe by spontaneously breathing premature infants.
Intervention Type
Device
Intervention Name(s)
Conventional bubble nasal CPAP
Intervention Description
Infants enrolled in the study and randomized to this arm will be given respiratory support by bubble nasal CPAP using the Fisher & Paykel bubbler device, which is the standard of care at Nationwide Children's.
Primary Outcome Measure Information:
Title
Failure of noninvasive respiratory support
Description
The primary endpoint of this study is the cumulative incidence of respiratory failure requiring intubation. The principal criteria for failure of support are the requirement of an FiO2 greater than 0.40 and CPAP of greater than 6 cm H2O to maintain SaO2 of at least 90%. Support failure also can be declared by the responsible clinician based on best clinical judgment, but any declarations not based on the stated criteria will require written explanations.
Time Frame
After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first.
Secondary Outcome Measure Information:
Title
pneumothorax
Description
by diagnosis of clinical care team
Time Frame
After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first.
Title
nasal trauma
Description
by diagnosis of clinical care team
Time Frame
After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first.
Title
supplemental oxygen requirement
Description
if an infant fails for one hour or more fails to sustain an oxygen saturation (SaO2) of at least 90 percent, with FiO2 of 0.40 or less and 6 cm of water pressure (cmH2O) or less CPAP pressure.
Time Frame
After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first.
Title
ventilation-associated sepsis
Description
by diagnosis of clinical care team
Time Frame
After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first.
Title
death of infant
Description
infant declared dead by responsible clinical care personnel
Time Frame
After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first.
Title
Central nervous system (CNS) injury
Description
intraventricular hemorrhage and/or periventricular leukomalacia
Time Frame
After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first.
Title
gastrointestinal complications
Description
necrotizing enterocolitis and/or spontaneous intestinal perforation
Time Frame
After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first.
Title
retinopathy of prematurity
Description
by diagnosis of clinical care team
Time Frame
After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first.
10. Eligibility
Sex
All
Maximum Age & Unit of Time
30 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed consent from parents, less than 30 weeks postmenstrual age at birth, within 72 h of postnatal age spontaneously breathing and able to sustain SaO2 of greater than 90% on less than or equal to FiO2 of 0.40 and 6 cm H2O pressure
Exclusion Criteria:
Cardiopulmonary malformations (cardiac valve atresia, lung atresia)
Congenital malformations (examples: anencephaly, omphalocele, Tetralogy of Fallot) Genetic anomalies (examples: Trisomy 21, Trisomy 18).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carl H Backes, Jr., MD
Phone
614 264-6374
Email
carl.backesjr@nationwidechildrens.org
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Stenger, MD
Phone
614 264-3555
Email
michael.stenger@nationwidechildrens.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl H Backes, Jr., MD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carl H Backes, Jr., MD
Phone
614-264-6374
Email
carl.backesjr@nationwidechildrens.org
First Name & Middle Initial & Last Name & Degree
Michael Stenger, MD
Phone
614 264-3555
Email
michael.stenger@nationwidechildrens.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be available for download via Globus sharing services from the Seattle-PAP shared endpoint.
Citations:
PubMed Identifier
20308940
Citation
Diblasi RM, Zignego JC, Tang DM, Hildebrandt J, Smith CV, Hansen TN, Richardson CP. Noninvasive respiratory support of juvenile rabbits by high-amplitude bubble continuous positive airway pressure. Pediatr Res. 2010 Jun;67(6):624-9. doi: 10.1203/PDR.0b013e3181dcd580.
Results Reference
background
PubMed Identifier
27837751
Citation
Welty SE. Continuous Positive Airway Pressure Strategies with Bubble Nasal Continuous Positive Airway Pressure: Not All Bubbling Is the Same: The Seattle Positive Airway Pressure System. Clin Perinatol. 2016 Dec;43(4):661-671. doi: 10.1016/j.clp.2016.07.004.
Results Reference
result
PubMed Identifier
20814347
Citation
Diblasi RM, Zignego JC, Smith CV, Hansen TN, Richardson CP. Effective gas exchange in paralyzed juvenile rabbits using simple, inexpensive respiratory support devices. Pediatr Res. 2010 Dec;68(6):526-30. doi: 10.1203/PDR.0b013e3181f985f0.
Results Reference
result
PubMed Identifier
23944299
Citation
Kirpalani H, Millar D, Lemyre B, Yoder BA, Chiu A, Roberts RS; NIPPV Study Group. A trial comparing noninvasive ventilation strategies in preterm infants. N Engl J Med. 2013 Aug 15;369(7):611-20. doi: 10.1056/NEJMoa1214533.
Results Reference
result
PubMed Identifier
30658678
Citation
Backes CH, Notestine JL, Lamp JM, Balough JC, Notestine AM, Alfred CM, Kern JM, Stenger MR, Rivera BK, Moallem M, Miller RR, Naik A, Cooper JN, Howard CR, Welty SE, Hillman NH, Zupancic JAF, Stanberry LI, Hansen TN, Smith CV. Evaluating the efficacy of Seattle-PAP for the respiratory support of premature neonates: study protocol for a randomized controlled trial. Trials. 2019 Jan 18;20(1):63. doi: 10.1186/s13063-018-3166-6.
Results Reference
derived
Learn more about this trial
A Study to Evaluate the Efficacy of Seattle-PAP for the Respiratory Support of Premature Infants
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